Ketogenic Diet Prior to Bariatric Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMaxima Medical Center
About this trial
Standard dietary regiments for bariatric are advised prior to surgery. The most used diet is a very low calorie diet (VLCD). These diets potentially have multiple pittfalls.
Very low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing bariatric surgery. The beneficial effect of VLCKDs compared to (V)LCDs is the aimed preservation of FFM and RMR, while still reducing FM. Only a few small studies addressed the role of VLCKDs prior to bariatric surgery, and the data including FFM and FM is actually scarce. Therefore, a well-designed randomised controlled trial is necessary to establish the efficacy of a VLCKD.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Eligible for bariatric surgery (≥35 kg/m2 with obesity-related comorbidities, or a BMI of
40 kg/m2 with or without comorbidities)
Roux-en-Y Gastric bypass (RYGB)
Disqualifiers
Weighing over 150kg because this amount is a limitation by the DXA device
Diabetes mellitus type 1
Allergic to milk proteins
A recent history of a heart attack (< 12 months), heart failure or cardiac arrhythmias
Trial design
Design model
Parallel
Treatments tested in this trial
VLCKD (ketogenic diet)
Dietary supplementdiets prior to bariatric surgery
VLCD (Very-low-calorie-diet)
Dietary supplementdiets prior to bariatric surgery
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: VLCD (Very-Low-Calorie-Diet)Active comparator 1 intervention
Group B: VLCKD (Very-Low-Calorie-Ketogenic-Diet)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in FFM (%) in proportion to TBWL
The main outcomes are the change in FFM (percentage) in proportion to total body weight loss (TBWL) measured from baseline to two weeks after start of the diet.
Time frame
2 weeks prior to surgery, day of surgery and 3 months after surgerySecondary outcomes
1
Change in weight
Weight (in kilograms), measured by Multi-frequency bioelectrical impedance analysis (MF-BIA), measured a total of three times. Twice before surgery: once prior to the diet and once after ending the diet. The last time 3 months after surgery
Time frame
2 weeks prior to surgery, day of surgery and 3 months after surgery2
Physical activity questionnaire
Measured by International Physical Activity Questionnaire (IPAQ). The IPAQ is used to estimate physical activity levels and to examine if there are differences in comparison to each diet and to assess differences preoperatively and postoperatively during and after completion of the diet. Measured in minutes per day. With a minimum of 0 minutes up to 1440 minutes a day. Higher scores might indicate higher levels of activity
Time frame
2 weeks prior to surgery, day of surgery and 3 months after surgery3
Patient satisfaction assessed by a questionnaire
5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied). To assess the degree of contentment in regard to each diet. Higher scores results in more satisfaction
Time frame
2 weeks prior to surgery, day of surgery and 3 months after surgery4
Incidence of side effects, assesed by questionnaire
Measured by self-reported questionnaires, making use of a dichotomous scale (Yes; No). With a score Yes indicating the occurence of a side effect.
Time frame
2 weeks prior to surgery, day of surgery and 3 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov